a telemedicine prenatal care model on low risk pregnants: the m@mae-e study

Conditions: Pregnancy; Mental Disorders; COVID-19 Pandemic; Prenatal Stress

Summary: this study will compare the effectiveness of a prenatal care supported by telemedicine against usual care in low-risk pregnant women. the investigators will follow-up women in a gestational age of 6 weeks up to 41 weeks, and 6 postpartum weeks. the primary outcome is the anxiety level estimated by the general anxiety scale 7 scale (gad-7 scale).

this is a pragmatic, effectiveness, superiority randomized clinical trial (rct), in which low risk pregnants will be randomized to a prenatal care program supported by telemedicine or usual care in an allocation ratio of 1:1. the follow-up period will last 41 weeks from inception (i.e., 6 to 13 weeks of gestational age) to pregnancy and a extension period of 6 weeks in the postpartum stage. the investigators settled anxiety levels estimated by the general anxiety scale 7 scale as primary outcome in a between-groups mean difference after the 3rd trimester. secondary outcomes include: delivery mode, obstetric events and fetal and neonatal variables of epidemiological surveillance interest (birth weight, birth height and apgar score; maternal, fetal and neonatal fatal and non-fatal events). the interventions will occur as follows: for usual care, all appointments (at least 9 outpatient clinic visits) will be carried forward in person by a senior obstetrician. patients randomized for the telemedicine supported group should will attend at least 6 in person and 3 online appointments. all pregnant women will receive the standardized care throughout the study. the sample size calculation was based on the primary outcome, assuming between-groups mean difference of 4 points plus a 4-points standard deviation, at a statistical of 80% and a two-tailed 5% type i error. further, a 15% of addition was done for potential impairments during the follow-up, ending in 30 patients per group. the m@mae-e study's setting will be the at santa casa de misericórdia, (porto alegre, brazil).

Eligibility criteria:
inclusion criteria: * low-risk pregnant (as classified an attending physician and/or the study's obstetrician); * gestational age less at 13 weeks or more in the moment of the first appointment; * portuguese native speaker. exclusion criteria: * pregnant involving: hypertension or diabetes mellitus (any type) previous diagnosis; * obesity (bmi equal or greater than 35 m/kg2; * previous diagnosis of severe sars-cov-2 2019-related (covid-19) infection which needed hospitalization; * previous thromboembolic event; * acute or chronic hematological events/diseases; use of anticoagulants or anti platelet aggregation drugs; * chronic cardiovascular, lung or kidney disease and cancer requiring treatment; * immunosuppression state; * severe mental disorder - major depression, generalized anxiety (and others anxiety-related disorders), bipolar disorder, schizophrenia and personality-related disorders in an uncontrolled manner for at least 1 year; * at least more than one abortion; * history of premature birth; * an enrolled patient living in the same house; * plan to move the city.

Keywords: prenatal care covid-19 telemedicine low risk prenatal line of care health policy randomized clinical trial